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Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Medical Centre Ljubljana.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00942006
First received: July 17, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.


Condition Intervention
Suspected Early Lyme Neuroborreliosis
 Drug: doxycycline
Drug: ceftriaxone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LNB-doxycycline Drug: doxycycline
100 mg bid, 14 days
Active Comparator: LNB-ceftriaxone Drug: ceftriaxone
2g x 1 iv, 14 days

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >15 years
  • erythema migrans in 4 months period before neurologic symptoms
  • normal CSF cell count
  • absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

Exclusion Criteria:

  • pregnancy
  • lactation
  • allergy on doxycycline and ceftriaxone
  • immune deficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942006

Contacts
Contact: Katarina Ogrinc, MD PhD +386 1 522 4217 katarina.ogrinc1@guest.arnes.si
Contact: Franc Strle, PhD MD +386 1 522 2110 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD PhD UMC Ljubljana
  More Information

No publications provided

Responsible Party: Katarina Ogrinc MD PhD, UMC Ljubljana
ClinicalTrials.gov Identifier: NCT00942006     History of Changes
Other Study ID Numbers: LNB-doxy-ceftriaxone
Study First Received: July 17, 2009
Last Updated: July 17, 2009
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
Lyme neuroborreliosis
Lyme borreliosis
erythema migrans
doxycycline treatment
 ceftriaxone treatment
outcome
subjective symptoms

Additional relevant MeSH terms:
Lyme Neuroborreliosis
Central Nervous System Bacterial Infections
Bacterial Infections
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
 Ceftriaxone
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013